Day Care in Robotic Surgery Hysterectomy. Investigate Quality of Life and Safety With Same Day Discharge After Robotic Hysterectomy for Patients With Benign and Malignant Disease. A Multicenter Randomized Study With 3 Hospitals in Stockholm Sweden.
NCT ID: NCT07233811
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-01-01
2028-01-31
Brief Summary
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Patients quality of life (QoL) will be measured before surgery and after surgery at day 3,7 and 30 with a questionnaire called Eq-5D-5L from Euroqol. The questionnaire is validated for postoperative QoL and widely used.
Complications due to surgery within the 30 first days after surgery will also be recorded in the two groups to make sure it is safe for the patients to go home the same day as their surgery.
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Detailed Description
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To measure Quality of Life, the validated Euroqol instrument EQ-5D-5L will be used. The EQ-5D-5L instrument is well validated and used in several studies. The literature support that a 5 points difference at the visaul analog scale (VAS) scale is significant for better/worse health QoL.
To measure patient satisfaction with the length of hospital stay and care given they will at day 30 receive an additional questionnaire, the "Quality in patent perspective" (QPP), which is a validated questionnaire in Swedish.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Day care
The patient returns to home the same day as the surgery is performed (before midnight)
Day care
The patient return to home the same day as the surgery is performed.
Overnight stay
The patient stay at the hospital overnight after their surgery.
Overnight stay
The patient spend the night at the hospital and can not go home until the next morning.
Interventions
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Overnight stay
The patient spend the night at the hospital and can not go home until the next morning.
Day care
The patient return to home the same day as the surgery is performed.
Eligibility Criteria
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Inclusion Criteria
* Both benign conditions and endometrial cancer.
* All BMI groups and all uterus sizes.
Exclusion Criteria
* No company at home first night after surgery
* ASA class 3 that is not only because of high BMI.
* Simultaneous prolapse surgery/lymph node evacuation.
* Severe endometriosis or patients with chronic pain conditions that have a special pain regimen after surgery.
18 Years
75 Years
FEMALE
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Malin Brunes
Principal Investigator
Principal Investigators
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Malin Brunes, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Södersjukhuset
Stockholm, , Sweden
Danderyd Hospital
Stockholm, , Sweden
Karolinska University hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-05648-01
Identifier Type: -
Identifier Source: org_study_id
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